Institutional Review Board Guidance

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Guidance

Note:  Posted Guidance documents on this website do not represent an all inclusive list. Not all current guidance documents are posted online as many are currently under revision. Please call the Office of the IRB at 210-567-2351 with any questions concerning current guidance.

Instructions:

Always return to this webpage to create new submissions to ensure you are using the most current Guidance.

Informed Consent Document Guidelines
Checklist for Elements of Informed Consent
Checklist for Elements of an Information Sheet
Guidelines for Advertising for Research Subjects
FDA Guidance on Study of Gender Differences in the Clinical Evaluation of Drugs
Existing Specimens -Guidelines for IRB Applications Involving the Use of Existing Specimens
Checklist for Final IRB-1 (Full Board Review) Submission
Waivers and Alterations Guidance
Policies Related to Vulnerable Populations
Policy Concerning Subject Identification and Recruitment
IRB Guidance on approval of research involving cognitively impaired subjects
IRB Guidance on Data and Safety Monitoring Plan
IRB Guidance on Reporting Emergency Use of HUD to Sponsor/IRB
Accounting for Disclosures Under HIPAA For Research
Assurance Letter

 
 
 
 

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